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NCT06122051Befejeződött

Dynamic Chest X-ray With Simultaneous Spirometry

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 15.

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Rövid összefoglaló (regiszter, angolul)

Dynamic chest X-ray (DCR) is a novel radiographic technique that enables us to visualise the movement of the chest and lungs in real-time by recording a series of x-ray images over 10-20 second interval. DCR provides an assessment of structures involved in respiration over a time period and could therefore provide us with insights into respiratory function. It may be possible that relating DCR to conventional breathing tests allows it to be used as a surrogate tool to measure lung function. Alternatively, it may provide different parameters of lung function which don't directly correlate with conventional testing, but are of themselves clinically relevant. Cystic fibrosis (CF) is a genetic condition that results in the body producing thick , dehydrated secretions. It is usually characterised by a cycle of recurring lung infections and inflammation resulting in progressive lung damage. A key clinical investigation for people with cystic fibrosis (pwCF), and other chest conditions, is a spirometry breathing test. Despite spirometry's fundamental role in chest medicine it can be poorly tolerated. In order to evaluate the utility of DCR as a tool for assessing lung function, it is important to be able to compare it to currently available pulmonary function tests such as spirometry. Previous studies have compared sequential lung function testing to DCR images; however, there may be significant variability in 2 separate manoeuvres as they are effort and technique dependent (i.e. when performing a DCR followed by spirometry or vice versa). Currently, there have been no studies that compare DCR with a simultaneous lung function test such as spirometry. This observational, prospective, non-randomised, single centre , pilot study aims to address this issue by performing simultaneous spirometry and DCR to establish how DCR compares with spirometry in a healthy population of individuals. The investigators would seek to also perform the DCR with simultaneous spirometry in a cohort of pwCF, allowing for comparison between the two groups. Furthermore DCR imaging has been part of the annual review process for pwCF at Liverpool Heart and Chest Hospital since 2019. The study investigators therefore intend to review how changes in DCR metrics over time relate to changes in other key clinical markers of pwCF, such as spirometry. A questionnaire on patient experiences of DCR will be provided to study participants to be filled in after imaging acquisition.

Állapot (regiszter)
Befejeződött
Vizsgálattípus
Megfigyeléses
Résztvevők száma
104 (tényleges)
Első benyújtás
2023. okt. 19.
Kezdés
2023. dec. 5.
Elsődleges befejezés
2025. júl. 31.
Fő szponzor
Liverpool Heart and Chest Hospital NHS Foundation Trust
NCT-szám
NCT06122051

Mit vállalsz

  • Vizsgálat típusa: Megfigyeléses
  • Bevont résztvevők: 104
  • 2023. dec. 5. és az elsődleges befejezés (2025. júl. 31.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

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Korábbi kezelés

  • Significant radiation exposure within the last year (for example, numerous CT scans of chest)
  • Involved, either currently or recently, in other studies involved non-routine exposure to sources of ionising radiation
  • Recent eye surgery or increased intraocular pressure
  • Recent thoracic or abdominal surgery

Más betegség

  • Any serious or active medical or psychiatric illness, which in the opinion of the investigators, would interfere with subject treatment, assessment, or compliance with the protocol
  • Current Chest infection
    • Spirometry exclusion criteria
    • Any of:
  • Unstable cardiovascular status, recent myocardial infarction or pulmonary embolism (within 6 weeks)
  • Undergoing treatment for tuberculosis
    • Part B: Real-time paired DCR and spirometry in a CF subgroup

Egyéb

  • General exclusion criteria:
  • Any of:
  • Potentially pregnant or lactating
  • Inability to provide informed consent
  • Unable or unwilling to sit to perform Dynamic chest x-ray/Spirometry in the radiology department
  • Unable or unwilling to follow Spirometry breathing instructions (e.g., holding breath or taking a deep breath)
  • Unable to perform reproducible spirometry and/or full pulmonary function studies within American Thoracic Society and European Society joint criteria
  • Inability to complete spirometry in 20 seconds.
  • Haemoptysis of unknown aetiology (within 6 weeks)
  • Pneumothorax (present, or occurring within 6 weeks)
  • Within 24 hours of bronchoscopy
  • Thoracic, abdominal or cerebral aneurysm
  • Acute nausea, vomiting or diarrhoea
  • Pregnancy

Kiket keres a vizsgálat

  • Age: ≥ 17 years old and <_ 50 years old
  • No underlying respiratory illness (chronic or acute). Individuals with an Asthma diagnosis requiring short-acting bronchodilators only will be eligible
  • Able to provide informed consent
  • Age: ≥ 17 years old and
  • Attending the adult CF Unit at Liverpool heart and Chest Hospital and
  • Confirmed CF diagnosis (positive sweat test in childhood and by genotyping) and
  • Able to provide informed consent
    • General exclusion criteria, same as Group A (see above) plus:
  • Recipient of Lung transplant
  • Current exacerbation Spirometry exclusion criteria (same as for Group A, see above)

A regiszterben nem jelölt feltételek

  • Part A: Real-time paired DCR and Spirometry in Healthy cohort with no underlying respiratory diagnosis

Életkor a regiszterben: 17 év – 50 év · Nem: nők és férfiak

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
Liverpool Heart and Chest HospitalLiverpoolEgyesült KirályságIsmeretlen állapot

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